Trial Title:
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT05572515
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Bortezomib
Pomalidomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Teclistamab
Description:
Teclistamab will be administered subcutaneously.
Arm group label:
Teclistamab
Other name:
JNJ-64007957
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
Pomalidomide will be administered orally.
Arm group label:
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib will be administered subcutaneously.
Arm group label:
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
Arm group label:
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Carfilzomib will be administered intravenously.
Arm group label:
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
Summary:
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1
and to further characterize safety and efficacy of an alternative dosing for teclistamab
in Part 2 in participants with relapsed or refractory multiple myeloma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented diagnosis of multiple myeloma as defined by the criteria below:
(a)Multiple myeloma diagnosis according to International Myeloma Working Group
(IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of
the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per
deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams
(mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain
>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum
immunoglobulin kappa lambda free light chain ratio
- Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2
consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal
antibody at the approved dosing regimen in any prior line and 2 consecutive cycles
of lenalidomide in any prior line
- Documented evidence of progressive disease or failure to achieve a response to last
line of therapy based on investigator's determination of response by International
myeloma working group (IMWG) criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- A female participant must agree not to be pregnant, breast-feeding, or plan to
become pregnant while enrolled in this study or within 6 months after the last dose
of study treatment
- Must be willing and able to adhere to the lifestyle restrictions specified in this
protocol
Exclusion Criteria:
- Received any prior B cell maturation antigen (BCMA)-directed therapy
- A participant is not eligible to receive PVd as control therapy if any of the
following are present: (1) Received prior pomalidomide therapy, (2) Does not meet
criteria for bortezomib retreatment (3) Contraindications or life-threatening
allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade
1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2
peripheral neuropathy as defined by National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong
cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A
participant is not eligible to receive Kd as control therapy if any of the following
are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension,
defined as an average systolic blood pressure greater than (>)159 millimeters of
mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3)
Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as
defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening
allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as
prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
- Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or
equivalent within 14 days prior to randomization
- Received a live, attenuated vaccine within 4 weeks before randomization
- Central nervous system (CNS) involvement or clinical signs of meningeal involvement
of multiple myeloma
- Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia,
polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin
changes, or primary amyloid light chain amyloidosis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology LLC
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Completed
Facility:
Name:
Alta Bates Comprehensive Cancer Center
Address:
City:
Berkeley
Zip:
94704
Country:
United States
Status:
Recruiting
Facility:
Name:
MemorialCare Long Beach Medical Center
Address:
City:
Long Beach
Zip:
90806
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
PIH Health Hospital
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Connecticut
Address:
City:
Farmington
Zip:
06030
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Florida
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer Blood
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
East Jefferson General Hospital Bone Marrow Transport Clinic
Address:
City:
Metairie
Zip:
70006
Country:
United States
Status:
Completed
Facility:
Name:
Walter Reed National Military Medical Center
Address:
City:
Bethesda
Zip:
20889
Country:
United States
Status:
Suspended
Facility:
Name:
Maryland Oncology Hematology P A
Address:
City:
Silver Spring
Zip:
20904
Country:
United States
Status:
Recruiting
Facility:
Name:
Boston University Medical Center
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Recruiting
Facility:
Name:
Saint Lukes Hospital Saint Lukes Cancer Specialists
Address:
City:
Chesterfield
Zip:
63017
Country:
United States
Status:
Completed
Facility:
Name:
Cooper Health System MD Anderson Cancer Center at Cooper
Address:
City:
Camden
Zip:
08103
Country:
United States
Status:
Recruiting
Facility:
Name:
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Durham VAMC
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Facility:
Name:
Penn Medicine Lancaster General Health
Address:
City:
Lancaster
Zip:
17601
Country:
United States
Status:
Recruiting
Facility:
Name:
Brooke Army Medical Center
Address:
City:
Fort Sam Houston
Zip:
78234
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor College of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Harris Health Smith Clinic
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Recruiting
Facility:
Name:
Utah Cancer Specialists
Address:
City:
Salt Lake City
Zip:
84106
Country:
United States
Status:
Recruiting
Facility:
Name:
Alexander T. Augusta Military Medical Center
Address:
City:
Fort Belvoir
Zip:
22060
Country:
United States
Status:
Suspended
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
NorthWest Medical Specialties, PLLC
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Blacktown Hospital
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincents Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Box Hill Hospital
Address:
City:
Melbourne
Zip:
3128
Country:
Australia
Status:
Recruiting
Facility:
Name:
Fiona Stanley Hospital
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
LKH - Universitätsklinikum der PMU Salzburg
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Medical University Vienna MUV
Address:
City:
Vienna
Zip:
A-1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Algemeen Ziekenhuis Klina
Address:
City:
Brasschaat
Zip:
2930
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Jolimont
Address:
City:
Haine-St-Paul
Zip:
7100
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Az Groeninge
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHR de la Citadelle
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Hospitais Integradaos da Gavea S/A - DF Star
Address:
City:
Brasilia
Zip:
70390-140
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Universidade de Caxias do Sul
Address:
City:
Caxias do Sul
Zip:
95070 560
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Paranaense de Combate ao Cancer
Address:
City:
Curitiba
Zip:
81520 060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Address:
City:
Joinville
Zip:
89201-260
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Norte Riograndense Contra O Cancer
Address:
City:
Natal
Zip:
59062 000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Complexo Hospitalar de Niteroi
Address:
City:
Niteroi
Zip:
24020-073
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Address:
City:
Rio de Janeiro
Zip:
22775-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sao Rafael
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
Address:
City:
Sao Jose do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Address:
City:
Sao Paulo
Zip:
01308-901
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto D Or de Pesquisa e Ensino IDOR
Address:
City:
Sao Paulo
Zip:
01401 002
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Clinica Medica Sao Germano LTDA
Address:
City:
Sao Paulo
Zip:
04537-081
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Real e Benemérita Associação Portuguesa de Beneficência
Address:
City:
São Paulo
Zip:
01321-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Alemao Oswaldo Cruz
Address:
City:
São Paulo
Zip:
01323-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Address:
City:
São Paulo
Zip:
05652-900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Arthur J. E. Child Comprehensive Cancer Centre
Address:
City:
Calgary
Zip:
T2N 5G2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Saint John Regional Hospital
Address:
City:
Saint John
Zip:
E2L 4L2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Brampton Civic Hospital
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Lakeridge Health Oshawa
Address:
City:
Oshawa
Zip:
L1G2B9
Country:
Canada
Status:
Recruiting
Facility:
Name:
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Address:
City:
Montreal
Zip:
H1T 2M4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Beijing Chaoyang Hospital
Address:
City:
Beijing
Zip:
100020
Country:
China
Status:
Recruiting
Facility:
Name:
BeiJing JiShuiTan Hospital
Address:
City:
Beijing
Zip:
102208
Country:
China
Status:
Recruiting
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
The Third Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Provincial Peoples Hospital
Address:
City:
Chengdu
Zip:
610032
Country:
China
Status:
Recruiting
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Completed
Facility:
Name:
Fujian Meidical University Union Hospital
Address:
City:
Fu Zhou
Zip:
350001
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat -Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
First affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin medical university cancer hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Completed
Facility:
Name:
The First Affiliated Hospital of NanChang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Fourth People s Hospital
Address:
City:
Shanghai
Zip:
200434
Country:
China
Status:
Recruiting
Facility:
Name:
Shengjing Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110055
Country:
China
Status:
Recruiting
Facility:
Name:
Shenzhen 2nd People's Hospital
Address:
City:
Shenzhen
Zip:
518025
Country:
China
Status:
Recruiting
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital
Address:
City:
Tian Jin
Zip:
300020
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430023
Country:
China
Status:
Recruiting
Facility:
Name:
Wuxi People s Hospital
Address:
City:
Wuxi
Zip:
214023
Country:
China
Status:
Completed
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Brno
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Ostrava
Address:
City:
Ostrava - Poruba
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha 2
Zip:
128 08
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Aalborg University Hospital
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Regionshospitalet Godstrup
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Odense Universitetshospital
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Vejle Sygehus
Address:
City:
Vejle
Zip:
7100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
CHU Amiens - Hopital Sud
Address:
City:
AMIENS cedex 1
Zip:
80000
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Côte de Nacre
Address:
City:
Caen cedex 9
Zip:
14003
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Grenoble
Address:
City:
Grenoble
Zip:
38700
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier du Mans
Address:
City:
Le Mans
Zip:
72000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Vincent de Paul
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Montpellier Hopital Saint Eloi
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Nantes
Address:
City:
Nantes Cedex 1
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint-Antoine
Address:
City:
Paris
Zip:
75012
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital de la Pitie Salpetriere
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Necker Enfants Malades
Address:
City:
Paris
Zip:
75743
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Universitaire du Cancer Toulouse Oncopole
Address:
City:
Toulouse
Zip:
31100
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Nancy - Hopital de Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Recruiting
Facility:
Name:
Medizinische Universitat Lausitz Carl Thiem
Address:
City:
Cottbus
Zip:
03048
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsmedizin Greifswald
Address:
City:
Greifswald
Zip:
17475
Country:
Germany
Status:
Recruiting
Facility:
Name:
Asklepios Klinik Altona
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Giessen und Marburg GmbH
Address:
City:
Marburg
Zip:
35043
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Tubingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Ulm
Address:
City:
Ulm
Zip:
89070
Country:
Germany
Status:
Recruiting
Facility:
Name:
Heinrich-Braun-Klinikum gGmbH
Address:
City:
Zwickau
Zip:
08060
Country:
Germany
Status:
Recruiting
Facility:
Name:
Alexandra General Hospital of Athens
Address:
City:
Athens Attica
Zip:
115 28
Country:
Greece
Status:
Recruiting
Facility:
Name:
Agios Andreas General Hospital of Patra
Address:
City:
Patra
Zip:
263 35
Country:
Greece
Status:
Recruiting
Facility:
Name:
G Papanikolaou Hospital of Thessaloniki
Address:
City:
Thessaloniki
Zip:
570 10
Country:
Greece
Status:
Recruiting
Facility:
Name:
Fortis Memorial Research Institute
Address:
City:
Gurgaon
Zip:
122002
Country:
India
Status:
Recruiting
Facility:
Name:
Bhagwan Mahaveer Cancer Hospital & Research Centre
Address:
City:
Jaipur
Zip:
302017
Country:
India
Status:
Recruiting
Facility:
Name:
Deenanath Mangeshkar Hospital and Research Centre
Address:
City:
Pune
Zip:
411004
Country:
India
Status:
Recruiting
Facility:
Name:
Hillel Yaffe Medical Center
Address:
City:
Hadera
Zip:
3810101
Country:
Israel
Status:
Recruiting
Facility:
Name:
Bnai Zion Medical Center
Address:
City:
Haifa
Zip:
31048
Country:
Israel
Status:
Recruiting
Facility:
Name:
Carmel Medical Center
Address:
City:
Haifa
Zip:
3436212
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel-Aviv
Zip:
64239
Country:
Israel
Status:
Recruiting
Facility:
Name:
A O U Sant Orsola Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Chiara AO Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Arcispedale Santa Maria Nuova - IRCCS
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Campus Bio Medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASUI Santa Maria della Misericordia di Udine
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale di Circolo e Fondazione Macchi
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Institute of Science Tokyo Hospital
Address:
City:
Bunkyo ku
Zip:
113 8519
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chiba Cancer Center
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ogaki Municipal Hospital
Address:
City:
Gifu
Zip:
503-8502
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shibukawa Medical Center
Address:
City:
Gunma
Zip:
377-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hitachi General Hospital
Address:
City:
Hitachi
Zip:
317-0077
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Medical University Hospital
Address:
City:
Iruma-gun
Zip:
350-0495
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kameda Medical Center
Address:
City:
Kamogawa City
Zip:
296-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277 8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kurashiki Central Hospital
Address:
City:
Kurashiki
Zip:
710-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
Matsuyama Red Cross Hospital
Address:
City:
Matsuyama
Zip:
790-8524
Country:
Japan
Status:
Recruiting
Facility:
Name:
Aichi Medical University Hospital
Address:
City:
Nagakute
Zip:
480-1195
Country:
Japan
Status:
Recruiting
Facility:
Name:
JRC Nagasaki Genbaku Hospital
Address:
City:
Nagasaki-Shi
Zip:
852-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata University Medical And Dental Hospital
Address:
City:
Niigata
Zip:
951 8520
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Okayama Medical Center
Address:
City:
Okayama
Zip:
701-1192
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka Metropolitan University Hospital
Address:
City:
Osaka
Zip:
545 8586
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Status:
Completed
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo
Zip:
113-0033
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135 8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-2331
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamanashi Prefectural Central Hospital
Address:
City:
Yamanashi
Zip:
400-8506
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hospital Pulau Pinang
Address:
City:
Georgetown
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Queen Elizabeth
Address:
City:
Kota Kinabalu
Zip:
88200
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Subang Jaya Medical Centre
Address:
City:
Subang Jaya
Zip:
47500
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Meander Medisch Centrum
Address:
City:
Amersfoort
Zip:
3813 TZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
VUMC Amsterdam
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9700 RB
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40 519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Address:
City:
Lublin
Zip:
20-081
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uls Almada Seixal - Hosp. Garcia de Orta
Address:
City:
Almada
Zip:
2805-267
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Uls Braga - Hosp. Braga
Address:
City:
Braga
Zip:
4710-243
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Champalimaud Foundation Champalimaud Centre
Address:
City:
Lisbon
Zip:
1400-038
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Instituto Portugues de Oncologia
Address:
City:
Porto
Zip:
4200072
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Hospital de Vila Nova de Gaia E.P.E.
Address:
City:
Vila Nova de Gaia
Zip:
4434-502
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Germans Trias I Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Catala d'Oncologia L'Hospitalet
Address:
City:
Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. de Jerez de La Frontera
Address:
City:
Jerez de la Frontera
Zip:
11407
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. de Leon
Address:
City:
Leon
Zip:
24008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Infanta Leonor
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. J.M. Morales Meseguer
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Son Llatzer
Address:
City:
Palma de Mallorca
Zip:
07198
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Montecelo
Address:
City:
Pontevedra
Zip:
36071
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Quiron Madrid Pozuelo
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
València
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Falu Lasarett Medicinkliniken Falun
Address:
City:
Falun
Zip:
791 82
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Helsingborgs lasarett
Address:
City:
Helsingborg
Zip:
25287
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Akademiska Sjukhuset
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Ankara Gulhane Training and Research Hospital
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara University Medical Faculty
Address:
City:
Ankara
Zip:
06620
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Liv Hospital Ankara
Address:
City:
Ankara
Zip:
06680
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Antalya Training And Research Hospital
Address:
City:
Antalya
Zip:
07100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ondokuz Mayis University
Address:
City:
Atakum
Zip:
55280
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Pamukkale University Medical Faculty
Address:
City:
Denizli
Zip:
20070
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medipol University Hospital
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Zip:
AB25 2ZN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B15 2GW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Colchester Hospital University NHS
Address:
City:
Colchester
Zip:
CO4 5JL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Clatterbridge Cancer Centre
Address:
City:
Liverpool
Zip:
L7 8YA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Chelsea And Westminster Hospital
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St George's Hospital
Address:
City:
London
Zip:
SW17 0QT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
James Cook University Hospital
Address:
City:
Middlesborough
Zip:
Ts4 3Bw
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Norfolk and Norwich University Hospital
Address:
City:
Norwich
Zip:
NR4 7UY
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Stoke University Hospital
Address:
City:
Staffordshire
Zip:
ST4 6QG
Country:
United Kingdom
Status:
Recruiting
Start date:
March 29, 2023
Completion date:
August 31, 2031
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05572515
